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The FDA has outlined the ways companies are expected to comply with postmarketing safety reporting (PMSR) requirements for combination products in final guidance issued Monday. Read More
The guidance says FDA’s Division of Antiviral Products will accept data from most NGS platforms, but sponsors ‘should submit a detailed protocol that describes sample processing and NGS analysis procedures.’ Read More
A federal grand jury in Cincinnati charged Ohio-based drug distributor Miami-Luken and two of its former executives with conspiring with doctors and pharmacies to illicitly sell millions of opioid pills in West Virginia, Ohio and Kentucky. Read More
The FDA cited non-sterile drug manufacturer PrecisionMed for ineffective cleaning to prevent cross-contamination of products at its Tampa, Florida facility. Read More
Population PK analysis is “especially appropriate in children” because it allows the use of sparse sampling, minimizing the total volume of blood sampled, the agency said. Read More
CDER released final guidance on Thursday on submitting next generation nucleotide sequence (NGS) data to support resistance assessments for antiviral drugs. Read More